Glenmark gets US drug regulator’s nod for high BP medicine

Mumbai (Maharashtra) [India], December 19 (ANI): Glenmark Pharmaceuticals (Glenmark) has received final approval by the US Food and Drug Administration (US FDA) for Nicardipine Hydrochloride capsules for 20 mg and 30 mg, the generic version of Cardene capsules of 20 mg and 30 mg of Chiesi US.

Nicardipine is used alone or together with other medicines to treat severe chest pain or high blood pressure. Glenmark’s Nicardipine Hydrochloride capsules of 20 mg and 30 mg will be distributed in the US by Glenmark Pharmaceuticals US, according to a statement from Glenmark. According to IQVIATM sales data for the 12-month period ending October 2022, the Cardene capsules of 20 mg and 30 mg market achieved annual sales of about $10.9 million.

Glenmark said its current portfolio consists of 178 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs)’s pending approval with the US FDA. In addition to these internal filings, Glenmark said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

The company said it has 10 most modern manufacturing facilities spread across four continents and operations in over 80 countries. Glenmark is ranked among the world’s top 100 biopharmaceutical companies, according to the company statement.